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<eudamedExport entity="devices">
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    <udiDi>00816870022451</udiDi>
    <basicUdiDi>B-00816870022451</basicUdiDi>
    <tradeName>C-Peptide &amp; Insulin AccuLite VAST CLIA Kit - 96 wells</tradeName>
    <deviceName>C-Peptide &amp; Insulin (C-Pep/ Ins VAST) AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7375-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:08:57.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022444</udiDi>
    <basicUdiDi>B-00816870022444</basicUdiDi>
    <tradeName>Myoglobin AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Myoglobin AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3275-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:08:54.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022437</udiDi>
    <basicUdiDi>B-00816870022437</basicUdiDi>
    <tradeName>Myoglobin AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Myoglobin AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3275-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:08:50.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022420</udiDi>
    <basicUdiDi>B-00816870022420</basicUdiDi>
    <tradeName>C-peptide AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>C-Peptide AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2775-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:08:47.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022369</udiDi>
    <basicUdiDi>B-00816870022369</basicUdiDi>
    <tradeName>cTnI AccuLite CLIA Kit - 192 wells</tradeName>
    <deviceName>Troponin-I (cTnI) AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3875-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:06:45.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022413</udiDi>
    <basicUdiDi>B-00816870022413</basicUdiDi>
    <tradeName>C-peptide AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060101</emdnCode>
    <emdnDescription>C-PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2775-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:06:41.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022383</udiDi>
    <basicUdiDi>B-00816870022383</basicUdiDi>
    <tradeName>DIG AccuBind CLIA Kit - 192 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>975-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:06:38.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022376</udiDi>
    <basicUdiDi>B-00816870022376</basicUdiDi>
    <tradeName>DIG AccuBind CLIA Kit - 96 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>975-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:06:35.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870022352</udiDi>
    <basicUdiDi>B-00816870022352</basicUdiDi>
    <tradeName>cTnI AccuLite CLIA Kit - 96 wells</tradeName>
    <deviceName>Troponin-I (cTnI) AccuLite® CLIA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3875-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:06:28.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021904</udiDi>
    <basicUdiDi>B-00816870021904</basicUdiDi>
    <tradeName>T3, T4 &amp; TSH AccuBind VAST ELISA Kit - 960 wells</tradeName>
    <deviceName>Total Triiodothyronine/ Total Thyroxine/ Thyrotropin (T3/ T4/ TSH VAST) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8025-300E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:06:24.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021898</udiDi>
    <basicUdiDi>B-00816870021898</basicUdiDi>
    <tradeName>T3, T4 &amp; TSH AccuBind VAST ELISA Kit - 480 wells</tradeName>
    <deviceName>Total Triiodothyronine/ Total Thyroxine/ Thyrotropin (T3/ T4/ TSH VAST) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8025-300D</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:06:21.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021881</udiDi>
    <basicUdiDi>B-00816870021881</basicUdiDi>
    <tradeName>T3, T4 &amp; TSH AccuBind VAST ELISA Kit - 192 wells</tradeName>
    <deviceName>Total Triiodothyronine/ Total Thyroxine/ Thyrotropin\n (T3/ T4/ TSH VAST) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8025-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:06:18.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021874</udiDi>
    <basicUdiDi>B-00816870021874</basicUdiDi>
    <tradeName>FT3, FT4 &amp; TSH AccuBind VAST ELISA Kit - 960 wells</tradeName>
    <deviceName>Free Triiodothyronine/ Free Thyroxine/ Thyrotropin (Free T3/ Free T4/ TSH VAST) AccuBind® ELISA</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7025-300E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:05:57.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021867</udiDi>
    <basicUdiDi>B-00816870021867</basicUdiDi>
    <tradeName>FT3, FT4 &amp; TSH AccuBind VAST ELISA Kit - 480 wells</tradeName>
    <deviceName>Free Triiodothyronine/ Free Thyroxine/ Thyrotropin (Free T3/ Free T4/ TSH VAST) AccuBind® ELISA</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7025-300D</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:05:54.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021850</udiDi>
    <basicUdiDi>B-00816870021850</basicUdiDi>
    <tradeName>FT3, FT4 &amp; TSH AccuBind VAST ELISA Kit - 192 wells</tradeName>
    <deviceName>Free Triiodothyronine/ Free Thyroxine/ Thyrotropin (Free T3/ Free T4/ TSH VAST) AccuBind® ELISA</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7025-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:05:50.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021843</udiDi>
    <basicUdiDi>B-00816870021843</basicUdiDi>
    <tradeName>AFP, hCG &amp; uE3 AccuBind VAST ELISA Kit - 96 wells</tradeName>
    <deviceName>Alfa-Feto Protein/ β-Human Chorionic Gonadotropin/ Unconjugated Estriol (AFP/ hCG/ uE3 VAST) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050202</emdnCode>
    <emdnDescription>ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8525-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:05:47.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021836</udiDi>
    <basicUdiDi>B-00816870021836</basicUdiDi>
    <tradeName>Rapid TSH AccuBind Elisa Kit - 192 Wells</tradeName>
    <deviceName>Rapid Thyrotropin (TSH-Rapid) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6025-300B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:05:26.478Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021829</udiDi>
    <basicUdiDi>B-00816870021829</basicUdiDi>
    <tradeName>Rapid TSH AccuBind ELISA Kit - 96 Wells</tradeName>
    <deviceName>Rapid Thyrotropin (TSH-Rapid) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6025-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:05:22.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021812</udiDi>
    <basicUdiDi>B-00816870021812</basicUdiDi>
    <tradeName>TSH AccuBind ELISA Kit - 960 wells</tradeName>
    <deviceName>Thyrotropin (TSH) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>325-300E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:05:19.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816870021805</udiDi>
    <basicUdiDi>B-00816870021805</basicUdiDi>
    <tradeName>TSH AccuBind ELISA Kit - 480 wells</tradeName>
    <deviceName>Thyrotropin (TSH) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>325-300D</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-10-10T14:05:15.698Z</lastUpdated>
  </row>
</eudamedExport>